Drug Approval | January 28, 2024
Shilpa Medicare updates on Europe GMP inspection at Unit 4, Jadcherla, Telangana
The company intends to respond to the two minor observations within the stipulated time
The company intends to respond to the two minor observations within the stipulated time
The matter of Arbitration between Shilpa Medicare Limited and Celltrion towards supply and distribution agreement
This product has sales of about US$ 20 million in Europe
The company has reported total income of Rs. 107.22 crores during the period ended September 30, 2023
This inspection is the fourth major regulatory inspection (after Russia, Canada and Brazil), cleared by this site in the past two years
The composition of ORAAL is protected by a granted patent in India until November 2033
This approval has come from the company's finished dosage form manufacturing facility
Shilpa Medicare Limited is the first company to receive approval for Manufacturing & Market of Pemetrexed Injection 10 ml, 50 ml, 85 ml, and 100 ml in India
The company is already marketing the 4 mg and 10 mg strengths
This is the second US FDA GMP inspection of this facility within one year
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